Regional pharmacovigilance centers: A cornerstone of drug safety information development
The decentralized pharmacovigilance system has been in operation in Korea to encourage spontaneous reporting of drug adverse events (AEs). Regional Pharmacovigilance Centers (RPVCs) have played a key role, with 28 centers operating as of 2025. The purpose of this study is to introduce the role of RPVCs in Korea's pharmacovigilance system. Annual individual case safety reports (ICSRs) from the Korea Adverse Event Reporting System (KAERS) between 2014 and 2024 were analyzed. The quantity and quality of ICSRs from RPVCs were compared with other sources. Also data on educational, promotional, and counseling activities were examined. From 2006 to 2013, as the number of RPVCs increased, the total ICSRs collected in Korea also rose proportionally. From 2014, RPVCs contributed about 70% of total ICSRs (Number of ICSRs: RPVCs vs. MAHs – 170,433 vs. 75,241). Their reports showed higher completeness than those from marketing authorization holders (MAH) (Completeness Score: RPVCs vs. MAHs – 95.4 vs. 70.4). RPVCs have actively promoted AE reporting through education and consultations, conducting 2,700 educational activities and 37,600 AE consultations in 2024 alone. As core parts of Korea’s pharmacovigilance system, RPVCs contribute significantly to drug safety and should further expand their role to strengthen pharmacovigilance efforts.
2025 Spring Convention